# K994030: Ontrak Testcup 5, Cat. 07 6481 7

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 27, 2000 after 62 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964355 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964355: Ontrak Testcup 5 (Modification), Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
OnTrak TesTcup® S is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup 5 profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 ng/mL) and PCP (25 ng/mL). OnTrak TesTcup 5 provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K994030
Methodology: https://510kreport.com/methodology